[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25550-25565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10875]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 482 and 485
[CMS-3227-F]
RIN 0938-AQ05
Medicare and Medicaid Programs: Changes Affecting Hospital and
Critical Access Hospital Conditions of Participation: Telemedicine
Credentialing and Privileging
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule will revise the conditions of participation
(CoPs) for both hospitals and critical access hospitals (CAHs). The
final rule will implement a new credentialing and privileging process
for physicians and practitioners providing telemedicine services.
Currently, a hospital or CAH receiving telemedicine services must go
through a burdensome credentialing and privileging process for each
physician and practitioner who will be providing telemedicine services
to its patients. This final rule will remove this undue hardship and
financial burden.
DATES: Effective Date: These regulations are effective on July 5, 2011.
FOR FURTHER INFORMATION CONTACT: CDR Scott Cooper, USPHS, (410) 786-
9465. Jeannie Miller, (410) 786-3164.
SUPPLEMENTARY INFORMATION:
I. Background
This final rule reflects the Centers for Medicare and Medicaid
Services' commitment to the general principles of the President's
Executive Order released January 18, 2011, entitled ``Improving
Regulation and Regulatory Review.'' The rule revises the conditions of
participation (CoPs) for both hospitals and critical access hospitals
(CAHs) to: (1) Make current Federal requirements more flexible for
rural and/or small hospitals and for CAHs; and (2) encourage innovative
approaches to patient-service delivery.
CMS regulations currently require a hospital to have a
credentialing and privileging process for all physicians and
practitioners providing services to its patients. The regulations
require a hospital's governing body to appoint all practitioners to its
hospital medical staff and to grant privileges using the
recommendations of its medical staff. In turn, the hospital medical
staff must use a credentialing and privileging process, provided for in
CMS regulations, to make its recommendations. CMS requirements do not
take into account those practitioners providing only telemedicine
services to patients. Consequently, hospitals apply the credentialing
and privileging requirements as if all practitioners were onsite. This
traditional and limited approach fails to embrace new methods and
technologies for service delivery that may improve patient access to
high quality care.
This final rule will permit hospitals and CAHs to implement a new
credentialing and privileging process for physicians and practitioners
providing telemedicine services. The removal of unnecessary barriers to
the use of telemedicine may enable patients to receive medically
necessary interventions in a more timely manner. It may enhance patient
follow-up in the management of chronic disease conditions. These
revisions will provide more flexibility to small hospitals and CAHs in
rural areas and regions with a limited supply of primary care and
specialized providers. In certain instances, telemedicine may be a
cost-effective alternative to traditional service delivery approaches
and, most
[[Page 25551]]
importantly, may improve patient outcomes and satisfaction.
As noted above, the current Medicare Hospital conditions of
participation (CoPs) for credentialing and privileging of medical staff
at 42 CFR Sec. 482.12(a)(2) and Sec. 482.22(a)(2) require the
governing body of the hospital to make all privileging decisions based
upon the recommendations of its medical staff after the medical staff
has thoroughly examined and verified the credentials of practitioners
applying for privileges, and after the staff has applied specific
criteria to determine whether an individual practitioner should be
privileged at the hospital. The current critical access hospital (CAH)
CoPs at 42 CFR 485.616(b) similarly require every CAH that is a member
of a rural health network to have an agreement for review of physicians
and practitioners seeking privileges at the CAH. The agreement must be
with a hospital that is a member of the network, a Medicare Quality
Improvement Organization (QIO), or another qualified entity identified
in the State's rural health plan. In addition, the services provided by
each doctor of medicine or osteopathy at the CAH must be evaluated by
one of these same three types of outside parties. These requirements
apply to all physicians and practitioners seeking privileges at the
hospital or CAH, respectively, regardless of whether services will be
provided in person and onsite at the hospital or CAH, or remotely
through a telecommunications system.
While hospitals may use third-party credentialing verification
organizations to compile and verify the credentials of practitioners
applying for privileges, the hospital's governing body is still legally
responsible for all privileging decisions. Similarly, each CAH is
required to have its privileging decisions made by either its governing
body or the person responsible for the CAH.
In the past, hospitals that were accredited by The Joint Commission
(TJC) were deemed to have met the Medicare CoPs, including the
credentialing and privileging requirements, under TJC's statutory
deeming authority. Section 125 of the Medicare Improvements for
Patients and Providers Act of 2008 (Pub. L. 110-275, July 15, 2008)
(MIPPA), terminated the statutory recognition of TJC's hospital
accreditation program, effective July 15, 2010. The law now requires
TJC to secure CMS approval of its standards in order to confer Medicare
deemed status on hospitals.
Under its previous statutory deeming authority, TJC has permitted
``privileging by proxy,'' which had allowed TJC-accredited hospitals to
privilege ``distant-site'' (as that term is defined at section
1834(m)(4)(A) of the Social Security Act (the Act)) physicians and
practitioners. TJC privileging by proxy standards allowed for one TJC-
accredited facility to accept the privileging decisions of another TJC-
accredited facility utilizing a streamlined independent determination
process, rather than making an individualized decision based on the
practitioner's credentials and record. Even though they were TJC-
accredited, hospitals that have used this method to privilege distant-
site medical staff technically did not meet the CMS requirements that
applied to other hospitals. When we learned of specific instances of
such noncompliance through on-site validation surveys by State survey
agencies, the hospital was required to change its policies to come into
compliance. However, the majority of Joint Commission-accredited
hospitals were not routinely subjected to validation surveys of their
privileging practices, and it appears that many of them were employing
the practices permitted by The Joint Commission.
With the loss of statutory status for its hospital accreditation
program, The Joint Commission is now required to conform its
accreditation program to the Medicare requirements, including the
provisions governing credentialing and privileging, and enforce it
accordingly in all of its accredited hospitals.
TJC-accredited hospitals, therefore, have been concerned that they
may be unable to meet the long-standing CMS privileging requirements
while sustaining their current telemedicine agreements. Small hospital
medical staffs, in particular, are concerned about the burden of
privileging hundreds of specialty physicians and practitioners that
large academic medical centers make available to them. Because of the
complexity of the issues, and to minimize disruption to accredited
hospitals and CAHs, we decided to allow additional time for The Joint
Commission to ensure conformity to the Medicare Conditions of
Participation (CoPs). Accordingly, we notified TJC that we would expect
implementation of its new accreditation standards no later than the
effective date of this final rule.
Upon reflection, we came to the conclusion that our present
requirement is a duplicative and burdensome process for physicians,
practitioners, and the hospitals involved in this process, particularly
small hospitals and CAHs, which often lack adequate resources to fully
carry out the traditional credentialing and privileging process for all
of the physicians and practitioners that may be available to provide
telemedicine services. In addition to the costs involved, small
hospitals and CAHs often do not have in-house medical staff with the
clinical expertise to adequately evaluate and privilege the wide range
of specialty physicians that larger hospitals can provide through
telemedicine services. The public comments we received on the proposed
rule, which we discuss in this final rule, overwhelmingly reinforced
this perception.
II. Provisions of Proposed Rule and Response to Comments
We published a proposed rule in the Federal Register on May 26,
2010 (75 FR 29479). In that rule, we proposed to revise both the
hospital and CAH credentialing and privileging requirements to
eliminate regulatory impediments and to allow for the advancement of
telemedicine nationwide.
While telemedicine is included under the broader scope of
telehealth, we consider telemedicine, as the term is used in the
proposed rule and as we use it here in this final rule, to be the
provision of clinical services to patients by practitioners from a
distance via electronic communications. The distant-site telemedicine
physician or practitioner provides clinical services to the hospital or
CAH patient either simultaneously, as is often the case with teleICU
services, for example, or non-simultaneously, as may be the case with
many teleradiology services. ``Simultaneously'' would mean that the
clinical services (for example, assessment of the patient with a
clinical plan for treatment, including any medical orders needed) are
provided to the patient in ``real time'' by the telemedicine
practitioner, similar to the actions of an on-site practitioner when
called in by a patient's attending physician to see the patient.
Generally, payment for telehealth services under section 1834(m) of the
Act, distinguished from ``telemedicine services'' as discussed here,
requires that services be provided to a patient in real time while the
patient is physically present at the originating site. ``Non-
simultaneously'' means that while the telemedicine practitioner still
provides clinical services to the patient upon a formal request from
the patient's attending physician, such services may involve after-the-
fact interpretation of diagnostic tests in order to provide an
assessment of the patient's condition and do not necessarily require
the telemedicine practitioner to directly assess the patient in ``real
time.'' This would be similar to the services
[[Page 25552]]
provided by an on-site radiologist who interprets a patient's x-ray or
CT scan and then communicates his or her assessment to the patient's
attending physician who then bases his or her diagnosis and treatment
plan on these findings. In fact, the actual location (distant-site
versus on-site) of the radiologist performing the readings is often the
major distinguishing factor between in-house radiologists and
teleradiologists. These services are not payable as ``telehealth
services'' under section 1834(m) of the Act because in addition to not
meeting the ``real time'' requirements, these services do not meet the
telehealth patient location requirements also contained under this
section of the Act and upon which the CMS telehealth payment
requirements are based.
We also indicated that the proposed revisions would preserve and
strengthen the core values of the credentialing and privileging process
for all hospitals, provide accountability to all patients, and assure
that medical staff are privileged to provide services in the hospital
based on evaluation of the practitioner's medical competency.
We provided a 60-day public comment period in which we received a
total of 113 timely comments from hospitals, CAHs, physicians,
professional organizations, providers of teleradiology interpretation
services, other specialty practitioners providing telemedicine
services, and hospital systems. Overall, the majority of commenters
were supportive of the proposed changes, but many also raised several
separate issues. The most common comment expressed was that the
proposed regulation did not go far enough in restructuring privileging
and credentialing requirements for telemedicine providers. Summaries of
the major issues and our responses are set forth below.
Hospital CoPs (Sec. 482.12 and Sec. 482.22)
The proposed revisions to the hospital CoPs for the credentialing
and privileging of telemedicine physicians and practitioners are
contained within two separate CoPs: Sec. 482.12, ``Governing body,''
and Sec. 482.22, ``Medical staff.''
For the Governing body CoP, we proposed to add a new paragraph,
Sec. 482.12(a)(8), which would require the hospital's governing body
to ensure that, when telemedicine services are furnished to the
hospital's patients through an agreement with a Medicare-participating
hospital (the ``distant-site'' hospital as defined at section
1834(m)(4)(A) of the Act), the agreement must specify that it is the
responsibility of the governing body of the distant-site hospital
providing the telemedicine services to meet the existing requirements
in Sec. 482.12(a)(1) through (a)(7) with regard to its physicians and
practitioners who are providing telemedicine services. These existing
provisions cover the distant-site hospital's governing body
responsibilities for its medical staff that all Medicare-participating
hospitals must meet.
We proposed at Sec. 482.12(a)(8) to allow the governing body of
the hospital whose patients are receiving the telemedicine services to
grant privileges based on its medical staff recommendations, which
would rely on information provided by the distant-site hospital, as a
more efficient means of privileging the individual distant-site
physicians and practitioners providing the services.
This provision would be accompanied by the proposed requirement in
the ``Medical staff'' CoP at Sec. 482.22(a)(3), which would provide
the basis on which the hospital's governing body, through its agreement
as noted above, could choose to have its medical staff rely upon
information furnished by the distant-site hospital when making
recommendations on privileges for the individual physicians and
practitioners providing such services. We specified that this option
would allow the hospital's medical staff to rely upon the credentialing
and privileging decisions of the distant-site hospital in lieu of the
current requirements at Sec. 482.22(a)(1) and (a)(2), which require
the hospital's medical staff to conduct individual appraisals of its
members and examine the credentials of each candidate in order to make
a privileging recommendation to the governing body. In the proposed
rule, we stated that this option would not prohibit a hospital's
medical staff from continuing to perform its own periodic appraisals of
telemedicine members of its staff, nor would it bar them from
continuing to use the traditional credentialing and privileging process
required under the current regulations. Our intent of this proposed
requirement was to relieve burden for smaller hospitals by providing
for a less duplicative and more efficient privileging scheme with
regard to physicians and practitioners providing telemedicine services.
However, in an effort to ensure accountability to the process, we
proposed within this same provision (Sec. 482.22(a)(3)) that the
hospital, in order to choose this less burdensome option for
privileging, would have to ensure that--(1) The distant-site hospital
providing the telemedicine services was another Medicare-participating
hospital; (2) the individual distant-site physician or practitioner was
privileged at the distant-site hospital providing telemedicine
services, and that this distant-site hospital provides a current list
of the physician's or practitioner's privileges; (3) the individual
distant-site physician or practitioner held a license issued or
recognized by the State in which the hospital whose patients are
receiving the telemedicine services is located; and (4) with respect to
a distant-site physician or practitioner granted privileges by the
hospital, the originating-site hospital had evidence of an internal
review of the distant-site physician's or practitioner's performance
under these telemedicine privileges and sent the distant-site hospital
this information for use in its periodic appraisal of the individual
distant-site physician or practitioner. We also proposed that the
information sent for use in the periodic appraisal would, at a minimum,
have to include all adverse events that did result or could have
resulted from telemedicine services provided by the distant-site
physician or practitioner to the originating hospital's patients, and
all complaints the originating site hospital had received about the
distant-site physician or practitioner.
Within the revisions to the hospital CoPs, we also proposed that
additional language be added to the current requirement at Sec.
482.22(c)(6), which requires that the hospital's medical staff bylaws
include criteria for determining privileges and a procedure for
applying the criteria to individuals requesting privileges. We proposed
to add language to stipulate that in cases where distant-site
physicians and practitioners were requesting privileges to furnish
telemedicine services through an agreement between hospitals, the
criteria for determining those privileges and the procedure for
applying the criteria would be subject to the proposed requirements at
Sec. 482.12(a)(8) and Sec. 482.22(a)(3).
Comment: We received several comments that are outside the scope of
this rule. Specifically, several commenters requested that we consider
establishing a central credentialing bank that would provide overall
clearance for telemedicine services, possibly through regional compacts
or reciprocity agreements. A number of commenters recommended that all
TJC-accredited facilities (including hospitals) be able to share
credentialing. A few commenters suggested that we establish a national
licensing process for physicians and other practitioners in order to
ease the
[[Page 25553]]
burden associated with credentialing and privileging.
Response: We thank all commenters for their comments, but are not
responding to these comments here because they are outside the scope of
this rulemaking.
Comment: The majority of commenters supported the changes proposed.
However, most of these commenters felt that the revisions to the CoPs
did not go far enough in addressing the burdens borne by those small
hospitals and CAHs that, through agreements and/or contracts, use the
telemedicine services of practitioners who are not part of the medical
staff of a Medicare-participating hospital. The commenters pointed out
that, under the proposed requirements, small hospitals and CAHs would
still be required to perform the duplicative and burdensome process of
credentialing and privileging practitioners that provide telemedicine
services through a distant-site telemedicine entity that is not a
hospital.
Several commenters provided examples of simultaneous and non-
simultaneous telemedicine services, such as teleradiology, teleICU,
teleneurology, and telepathology, where distant-site physicians and
practitioners provide radiology, ICU/critical care medicine, neurology,
and pathology services to hospital and CAH patients under the auspices
of a non-hospital entity that is nationally accredited as having met a
national accreditation organization's (AO) standards for credentialing
and privileging of medical staff (in addition to other standards
established by the national AO). Many commenters specifically mentioned
the TJC's Ambulatory Care accreditation program, which surveys and
accredits nearly 2,000 ambulatory care entities (of which these non-
hospital telemedicine entities, along with ambulatory surgery centers,
imaging centers, and dentist offices, are included) out of
approximately 30,500 ambulatory care entities nationwide. Commenters
suggested that CMS include these telemedicine entities in the
requirements so that small hospitals and CAHs would be able to enter
into agreements with them.
Many commenters stated that including the medical staff of these
distant-site telemedicine entities as part of an optional and
streamlined credentialing and privileging process, as we have already
proposed for distant-site Medicare-participating hospitals, would
increase the overall effectiveness of this rule. They posited that if
the goals of this rule were to greatly improve patient care by
increasing patient access to specialty services and reduce the burdens
and costs for hospitals and CAHs by removing the impediment of the
traditional credentialing and privileging process, then excluding
distant-site telemedicine entities would severely limit such goals. In
addition, commenters stated that telemedicine practitioners are part of
a growing national network that is supported by both hospitals and non-
hospital telemedicine entities.
Response: We appreciate the comments supporting the rule as well as
the suggestions for improving the rule. When drafting the proposed
rule, we gave much thought and consideration to ideas that were similar
to those that commenters have expressed regarding the inclusion of non-
hospital telemedicine entities as part of these requirements. After
careful consideration of the comments and the options available to us
for revising the proposed rule, we have concluded that it is important
that the medical staff of a distant-site telemedicine entity, which is
not a Medicare-participating hospital, be included in an optional and
streamlined credentialing and privileging process for those hospitals
and CAHs electing to enter into agreements for telemedicine services
with such entities. We believe that this inclusion would draw us
significantly closer to accomplishing the stated goals of this rule,
which are--(1) Increasing patient access to specialty services; and (2)
reducing burden on small hospitals and CAHs.
However, this decision presented significant challenges to us as we
sought to balance our desire to achieve the worthy goals noted above
with the equally important mission of ensuring, through our regulatory
authority and responsibility, the health and safety of all patients. As
we contemplated revisions to the proposed rule that would broaden its
application, the most significant challenge that we faced was
reconciling inclusion of distant-site telemedicine entities into this
new streamlined process without CMS having any regulatory or oversight
authority over these entities. We also note that we do not have any
oversight or approval process for accreditation programs (such as that
of TJC) for these entities. This situation differs greatly from our
proposed inclusion of other Medicare-participating hospitals, where we
are assured through the State survey or Medicare-approved accreditation
processes that distant-site hospitals providing telemedicine services
are in compliance with our CoPs, particularly those pertaining to
credentialing and privileging of medical staff.
In addition, we note that there is no statutory definition for a
telemedicine entity contained in the Act. Therefore, for the purposes
of this rule, we are defining a distant-site telemedicine entity as one
that--(1) Provides telemedicine services; (2) is not a Medicare-
participating hospital (therefore, a non-Medicare-participating
hospital that provides telemedicine services would be considered a
distant-site telemedicine entity also); and (3) provides contracted
services in a manner that enables a hospital or CAH using its services
to meet all applicable CoPs, particularly those requirements related to
the credentialing and privileging of practitioners providing
telemedicine services to the patients of a hospital or CAH.
Taking all of these factors into consideration, we came to the
conclusion that any revisions to the regulatory language finalized here
would need to hold distant-site telemedicine entities accountable to
the originating-site hospital for meeting CMS practitioner
credentialing and privileging standards. Likewise, hospitals and CAHs
using telemedicine services will need to provide, upon request when
surveyed, the most current telemedicine services agreement showing that
the distant-site entities providing the services are required to comply
with the CMS standards (even though CMS has no direct authority over
those entities) in order for the hospital or CAH to make use of the
more streamlined process when credentialing and privileging
practitioners from these distant-site telemedicine entities. Similar to
our regulations proposed for hospitals and CAHs using the telemedicine
services of distant-site Medicare-participating hospitals, the written
agreement between the hospital or CAH and the distant-site telemedicine
entity will be the foundation for ensuring accountability on both
sides. However, due to the differences already discussed between
Medicare-participating distant-site hospitals providing telemedicine
services and distant-site telemedicine entities providing similar
services, there must also be differences in the way the regulations are
written.
Therefore, in addition to the proposed requirements, we are also
finalizing new provisions that will apply to the credentialing and
privileging process and the agreements between hospitals or CAHs and
distant-site telemedicine entities (Sec. 482.12(a)(9) and Sec.
482.22(a)(4) for hospitals; Sec. 485.616(c)(3) and (c)(4) for CAHs).
These new provisions will require the governing body of the hospital
(or the CAH's governing body
[[Page 25554]]
or responsible individual), through its written agreement with the
distant-site telemedicine entity, to ensure that the distant-site
telemedicine entity, acting as a contractor of services, furnishes its
services in a manner that enables the hospital (or CAH) to comply with
all applicable conditions of participation and standards. For the
contracted services, the applicable CoPs and standards include, but are
not limited to, the credentialing and privileging requirements for
distant-site physicians and practitioners providing telemedicine
services.
For hospitals, we have directly linked this new requirement to an
existing requirement at Sec. 482.12(e), which requires the hospital's
governing body to ensure that a contractor of services to the hospital
(in this case, the distant-site telemedicine entity) furnishes services
that permit the hospital to comply with all applicable conditions of
participation and standards for contracted services. The applicable
conditions of participation and standards would include the
credentialing and privileging requirements as currently found at Sec.
482.12(a)(1) through (a)(7) of this section and would apply (in
accordance with the hospital's policy) to the telemedicine entity's
physicians and practitioners that provide telemedicine services to the
hospital's patients.
For CAHs, we also linked these new requirements to an existing
requirement (at Sec. 485.635(c)(4)) that, like Sec. 482.12(e) for
hospitals, pertains to contactors of services and the CAH governing
body's (or responsible individual's) obligation to ensure that
contracted services are furnished in a manner that enables the CAH to
meet all applicable conditions of participation and standards. The
standard also contains a provision, at Sec. 485.635(c)(1), that
requires the CAH to have agreements or arrangements with one or more
Medicare-participating providers or suppliers in order to furnish other
services to its patients. We see the ``Medicare-participating''
modifying provision as an impediment to the type of agreements that
CAHs may now have with distant-site telemedicine entities under this
final rule. Since these entities are not considered Medicare-
participating providers or suppliers by CMS, we needed to make an
exception to the requirement at Sec. 485.635(c)(1). Therefore, in this
final rule, we are adding a new paragraph at Sec. 485.635(c)(5) to
provide an exception to this ``Medicare-participating'' requirement for
telemedicine entities in cases where a written agreement exists between
a CAH and such entity.
We believe that the combination of the new requirements, as
finalized here, and the existing requirements cited above and in the
final requirements, which place responsibility on hospitals and CAHs to
ensure that contracted services fully enable them to meet the CoPs,
will allow hospitals and CAHs to make full use of the telemedicine
services offered by non-hospital telemedicine entities without
duplicating the credentialing and privileging process. This final rule
will now allow hospitals and CAHs to take advantage of these
streamlined credentialing and privileging options when using the
telemedicine services of other Medicare-participating hospitals, non-
Medicare-participating telemedicine entities, or a combination of both
types of service providers. And with these new requirements dually
aimed at increasing patient access to care and reducing the regulatory
burden on hospitals and CAHs, CMS believes that the potential of
telemedicine can be more fully realized while still maintaining
essential health and safety protections.
Comment: A number of commenters stated that practitioner-to-
practitioner ``tele-emergency'' video communications should not require
credentialing and privileging of the distant-site practitioner. Another
commenter requested that CMS consider that full credentialing and
privileging should not be required when telemedicine services are only
consultative in nature. However, the commenter did not clarify what he
or she meant by ``consultative'' services.
Response: Any time services are provided to a patient in a hospital
or CAH, the requirements regarding the credentialing and privileging of
the practitioners providing the services would apply, whether such
practitioners were onsite or available to the patient through
telemedicine services.
Regarding ``consultative'' services as mentioned by the commenter,
it is important to distinguish between informal consultation among
practitioners (traditionally known as a ``curbside consult''), and the
furnishing of professional consultation services, which would include
providing medical diagnosis and treatment recommendations to patients
after a formal request for such services by the practitioner
responsible for patient's care. The CMS privileging requirements do not
apply in instances where, for example, the attending physician of
record seeks informal advice from another physician(s) by whatever
communications media the physicians choose to use. The physician whose
advice is being sought is not providing clinical services to the
patient, but is merely rendering an informal opinion on the patients'
condition to the patient's attending physician, who may or may not make
use of the opinion when treating the patient. Such discussions between
medical professionals occur on a routine basis in hospitals across the
nation and do not require that the practitioners involved be privileged
at the same hospital in order for this exchange of medical opinions to
take place; in fact, we believe such communications may promote safer,
more effective care for patients. Only the attending physician, who is
providing clinical services to the patient, would need to be privileged
by the hospital or CAH to provide such services. However, a formal
consult provided by a specialty or other type of practitioner, where
the hospital or CAH patient receives clinical services from the
specialty practitioner after the patient's attending physician requests
such services be provided (either simultaneously as is often the case
with teleICU services, or non-simultaneously as may be the case with
many teleradiology services), would require that the practitioner is
privileged to do so at the hospital or CAH where the patient is
located.
Comment: One commenter stated that to further reduce burden, we
should consider a ``contract'' approach to credentialing and
privileging for telemedicine services, particularly for consultations
requested by referring providers. Some commenters stated that such
agreements or contracts, which essentially allow for credentialing and
privileging by proxy, leave hospitals vulnerable to legal liabilities
and risks and, therefore, should be prohibited under this rule. Another
commenter suggested that, with regard to legal risks and liabilities,
mandatory language addressing these issues should be required within
the written agreements between distant-site hospitals and the hospital
or CAH where the patient receives the services.
Response: The requirements, as proposed, are aimed at reducing the
telemedicine credentialing and privileging burden for small hospitals
and CAHs by specifically allowing for contracts or, as we refer to
them, ``agreements,'' between a distant-site hospital or telemedicine
entity providing the telemedicine services and a hospital or CAH that
uses these services for the benefit of its patients. In these
agreements, it is the responsibility of the hospital or CAH using the
services to ensure that the specifics of
[[Page 25555]]
the proposed requirements in this rule are explicitly laid out before
entering into such an arrangement. Along these lines, we have corrected
an oversight in the proposed rule and have revised the requirements in
this final rule to clarify that these agreements must be ``written.''
It has always been the intent of this rule to allow for hospitals and
CAHs to have the option of credentialing and privileging the distant-
site telemedicine practitioners using the traditional process.
Hospitals and CAHs electing to use the traditional credentialing and
privileging process must not be compelled by a distant-site
telemedicine hospital (or distant-site telemedicine entity) to enter
into an agreement that requires the use of the more streamlined
approach as outlined here.
Regarding the legal risks and liabilities of such agreements, the
governing body of each individual hospital and CAH must weigh the risks
and benefits of opting for this more streamlined process of
credentialing and privileging telemedicine practitioners. We understand
that there are many complex legal issues, including issues of
liability, inherent to contracts and agreements between institutions.
However, we believe that these issues are beyond the scope of this
rule, and that any relevant legal issues must be worked out between the
parties entering into the agreements in accordance with other laws and
regulations governing such contracts or agreements.
Comment: One commenter cited Sec. 482.12(b), under the ``Exercise
of rights'' standard in the Patients Rights CoP, to state that the rule
must contain language that requires the hospital or CAH to inform the
patient about the use of telemedicine services for diagnostic care, so
that the patient (or the patient's representative as allowed under
State law) may make an informed decision about whether to accept or
decline care provided in this way. The commenter believes that the
patient's informed consent must be obtained by the hospital or CAH
before it makes use of the telemedicine services.
Response: We respectfully disagree with the commenter. In
accordance with 42 CFR 482.24(c)(2)(v), the medical staff generally
specifies procedures and treatments, in addition to those required by
applicable Federal or State law, that require informed consent. As long
as the telemedicine practitioner is performing his or her duties within
the privileges granted by the hospital or CAH, there is no difference
between distant-site practitioners and in-house or on-site
practitioners in this regard. If they provide treatment that, under
medical staff policy, requires informed consent, then this consent must
be obtained, regardless of whether the treatment is furnished using
telemedicine or not. Likewise, if, as is typical, hospital medical
staff or CAH professional staff policies do not require the patient's
informed consent in order for an on-site radiologist to interpret an x-
ray or CT scan that had been performed on the patient, then consent
also would not be required when a distant-site telemedicine
radiologist, who is privileged by the hospital or CAH to interpret such
diagnostic radiological tests, performs the same services.
Comment: One commenter expressed concern that there is no incentive
for a distant-site hospital to provide these services for independent
physician groups without corporate affiliation, even if they happen to
be on the distant-site hospital medical staff.
Response: While it is not clear to whom this comment is referring
(``* * * independent physician groups without corporate affiliation,
even if `they' happen to be on the distant-site hospital medical staff
* * *''), the intent of this rule is not to provide business incentives
for the provision of telemedicine services (as we believe they exist
already), but to provide a more streamlined process for credentialing
and privileging telemedicine practitioners that would be more efficient
and less burdensome for all of the hospitals, CAHs, and distant-site
hospitals involved in this process. We believe that by allowing for
such an optional process, the incentives for distant-site hospitals to
provide telemedicine services and for hospitals and CAHs to make use of
these services will not diminish, but will greatly increase.
Ultimately, we believe this will lead to even greater patient access to
timely care that might not otherwise be available.
Comment: A commenter questioned the long-run sustainability of
increased workload associated with telemedicine (both at the patient-
site and at the distant-site facility), which, in the commenter's
opinion, seems inevitable. The commenter also questioned whether our
revisions would meet quality of care objectives within the commenter's
facility.
Response: The goal of this proposed rule is to ensure that all
patients have access to quality care in their communities. We believe
that this rule provides the framework for such care. We also believe
that providers and practitioners will continue to schedule patient
visits and appropriately refer patients in such a manner as to not
overwhelm either facility or its practitioners. We believe that this
rule will increase patient access to specialty services and reduce
burden on facilities and providers.
Comment: One commenter believes that CMS should assess the impact
of the final rulemaking on practitioners. A few commenters stated that
these requirements will increase burden on practitioners, because they
will experience significant downstream reporting requirements for
purposes of medical licensure renewal.
Response: It is not clear from the comments as to whom the
commenters are referring with the term, ``practitioners.'' Assuming
that the commenters means those physicians and practitioners who are
providing telemedicine services, we do not believe that this rule will
increase the burden of reporting requirements for license renewal any
more than the traditional credentialing and privileging processes
presently do.
Comment: Two commenters expressed support for the proposed
regulation and requested that it be expanded to include small hospitals
under 100 beds, as opposed to just rural hospitals that are
participating in a State-approved telemedicine program. One commenter
expressed concern that community-based facilities, which are neither
hospitals nor CAHs (such as rural health clinics and federally
qualified health centers), are not included in this rule as patient-
site facilities. Another commenter requested that we expand the scope
of the rule to all facilities regulated by Medicare.
Response: We would like to thank the commenters for their support
of the proposed rule. However, we would like to clarify that this rule
applies to all Medicare-participating hospitals, regardless of facility
size, as well as to all Medicare-participating CAHs. Rural health
clinics and federally qualified health centers are subject to separate
Medicare Conditions for Coverage that do not require credentialing and
privileging of their physicians and practitioners, and thus there is no
basis for extending this rule to those types of facilities. However, it
should be noted that many insurers, including Medicare, may place
limits or restrictions on their payment for telehealth services,
depending on the location of the patient who receives those services.
Comment: Two commenters stated their opposition to the proposed
rule because they felt that it allowed privileging by proxy to which
they are opposed. One commenter stated that the changes only invite
misuse by hospital and CAH governing bodies seeking to sidestep medical
staff decisions regarding credentialing and privileging
[[Page 25556]]
and to place direct economic pressure on hospital-based practitioners
(with the threat of replacing them with distant-site practitioners).
The commenter further stated that the changes will effectively remove
the local medical staff from any obligation that they may have in
determining the qualifications of each individual applying for
privileges.
Response: We respectfully disagree with the commenter. As we have
stated previously, the requirements being finalized here are an option
for hospitals and CAHs as they approach the credentialing and
privileging process for telemedicine practitioners. Though we cannot
estimate the numbers, we fully expect some hospitals and CAHs to
continue credentialing and privileging telemedicine practitioners
through the traditional process. Such decisions will have to be
determined and agreed upon by each hospital and CAH, after the risks
and benefits of each process are fully analyzed. Furthermore, since the
practice of privileging by proxy has been common for TJC-accredited
hospitals for several years now, there has been ample time for
problems, such as the ones the commenter mentions, to come to light. We
are not aware of any evidence that indicates these problems have arisen
from this process.
Comment: A few commenters expressed belief that some language we
used throughout the proposed rule is ambiguous and confusing and
suggested that the terms ``distant-site hospital'' and ``patient-site
facility'' be used consistently. Another commenter requested that we
use the terms ``distant site'' and ``originating site'' to ensure
consistency among CMS publications and avoid confusion. Another
commenter requested that we clarify the nomenclature within the
regulation so the responsibilities of each facility are explicit.
Response: In drafting the proposed rule, we gave much thought to
the terms that we would use to describe, and distinguish between, the
hospital that provides the telemedicine services and the hospital or
CAH that receives the telemedicine services on behalf of its patients.
We came to the conclusion that it would only be more confusing (for a
number of reasons) to use the terms ``distant site'' and ``originating
site,'' as they are contained in both the Act and the payment rules.
First among these reasons is the fact that, under the Act, there are
sites (for example, rural health clinics, federally qualified health
centers, and physician and practitioner offices) that are defined as
``originating,'' but which do not apply in the context of the hospital
and CAH CoPs. Additionally, the Act applies restrictions to these
originating sites for specific Medicare payment purposes, which have no
bearing on the hospital and CAH CoPs.
We also considered other terms, such as ``patient-site facility,''
but found them too vague and inappropriate as well. Upon final analysis
and consideration, we decided that distant-site hospital was an
appropriate term to describe those larger hospitals that provide
telemedicine services to patients of smaller hospitals and CAHs.
In considering which term to use for a hospital or CAH whose
patients receive telemedicine services, it became readily apparent to
us that the clarity of the language in the proposed requirements was
best served if we continued to use the terms used throughout the
current hospital and CAH CoPs to describe the facility to which the
CoPs applied and to which a survey (through either the State agencies
or the national accreditation organizations) for compliance with the
CoPs would be performed. Put simply, the hospital would be referred to
as the ``hospital'' and the CAH as the ``CAH.'' Any qualifying language
preceding these terms might change the meaning and confuse which
facility these CoPs applied. In some areas, we found it necessary to
use qualifying phrases such as ``the distant-site hospital providing
the telemedicine services'' and ``the hospital (or CAH) whose patients
are receiving the telemedicine services.'' Therefore, we are finalizing
these terms as proposed.
Comment: One commenter requested that we define and distinguish the
differences between telemedicine and telehealth.
Response: In drafting this rule, we reviewed a variety of existing
definitions of telemedicine and telehealth. The American Telemedicine
Association states that ``videoconferencing, transmission of still
images, e-health including patient portals, remote monitoring of vital
signs, continuing medical education, and nursing call centers are all
considered part of telemedicine and telehealth.'' Other organizations
describe telemedicine as one part of a larger category of telehealth.
The Institute of Medicine of the National Academy of Science defines
telemedicine as ``the use of electronic information and communication
technologies to provide and support health care when distance separates
the participants.'' According to the California Telemedicine and
eHealth Center, ``telehealth refers to a broader scope of services that
includes telemedicine, but it also includes other services that can be
provided remotely using communication technologies.'' And the federal
Office for the Advancement of Telehealth, describes telehealth as
``including telemedicine and a variety of other services.'' In
addition, Section 1834(m) of the Social Security Act (the Act)
addresses Medicare payment for ``telehealth services.'' In accordance
with those statutory provisions, telehealth services are certain
services provided by practitioners via a telecommunications system to
patients of certain types of healthcare facilities (including hospitals
and CAHs) and physician or practitioner offices that are located in
rural areas.
The consensus in the telemedicine/telehealth community appears to
be that telemedicine refers to the provision of clinical services to
patients by practitioners from a distance via electronic communications
and that it is included under the broader scope of telehealth, while
the statutory Medicare telehealth payment provisions are considerably
narrower. At Sec. 1834(m) of the Act, telehealth services are defined
as professional consultations, office visits, and office psychiatry
services, and any additional service specified by the Secretary. Most
significantly, the statute allows payment for services that are
provided to patients in a variety of settings (otherwise known as
``originating sites'' and which include physician or practitioner
offices, CAHs, rural health clinics, and hospitals), but requires that
all of these originating sites must be located in one of three areas:
(1) An area that is designated as a rural health professional shortage
area under section 332(a)(1)(A) of the Public Health Service Act (42
U.S.C. 254e(a)(1)(A)); (2) in a county that is not included in a
Metropolitan Statistical Area; or (3) from an entity that participates
in a Federal telemedicine demonstration.
However, for the purposes of this rule, we see telemedicine as
encompassing the overall delivery of healthcare to the patient through
the practice of patient assessment, diagnosis, treatment, consultation,
transfer and interpretation of medical data, and patient education all
via a telemedicine link (for example, audio, video, and data
telecommunications as may be utilized by distant-site physicians and
practitioners), and which is not restricted to only patients in rural
areas of the nation. Therefore, in order to make clear that the
credentialing and privileging provisions finalized here apply to all
Medicare-participating hospitals and CAHs and not to the narrower
subset of services and sites eligible for Medicare telehealth payment,
we chose to use the term,
[[Page 25557]]
``telemedicine,'' throughout this rule instead of ``telehealth.''
Comment: Two commenters stated that they do not support using the
phrase ``hospital's patients.'' They stated that often individuals who
are not registered patients make use of a rural hospital's telemedicine
facilities without being registered patients. Two other commenters
encouraged us to recognize and apply the proposed credentialing and
privileging model to ``all types of patients.'' One commenter requested
clarification of the word ``patient'' and suggests we further define
that any reference to patient applies solely to inpatient services.
Response: We are aware that individuals that are not patients
sometimes make use of a rural hospital's or CAH's facilities and
telemedicine equipment in order to effect what are essentially office
visits with distant-site telemedicine practitioners. Since these
individuals are not patients of the hospital or CAH, and the distant-
site telemedicine practitioners are not seeing them as patients of the
hospital or CAH, the CoPs would not apply in these situations. This
speaks directly to the other comments above requesting that these
requirements be applied to all types of patients and, conversely, that
we clarify that these requirements apply only to inpatients. Simply
stated, the hospital and CAH CoPs are intended to ensure the health and
safety of those patients, inpatients as well as outpatients, who are
hospital and CAH patients.
Comment: A commenter expressed concern that patient-site hospitals
may not have staff with appropriate expertise that would allow them to
evaluate credentialing and privileging information for specialists.
Response: The proposed and final rules address the commenter's
concern. Small hospitals and CAHs that believe they lack the expertise
to perform credentialing and privileging for the telemedicine services
of specialized practitioners already privileged at a distant-site
hospital or telemedicine entity would have the option of relying upon
the distant site's privileging process instead.
Comment: A commenter questioned whether it is sufficient for a
distant-site hospital to provide the information in an agreement with
the partnering patient-site institution. The commenter asked if the
distant-site hospital is expected to provide the patient-site hospital
with detailed information that may be contained in the physician's
credentialing file at the distant-site hospital.
Response: We would expect the parties engaged in the agreement to
determine, within the written details of the agreement or contract, how
much information would need to be included and sent for each
practitioner providing telemedicine services to the hospital or CAH. At
the very least, as part of its agreement with the distant-site
hospital, we would expect a hospital or CAH to have access to the
complete credentialing and privileging file upon request for each
practitioner who is covered by the agreement.
Comment: We received a number of comments concerning the issue of
State licensure and telemedicine practitioners. A few commenters stated
that a telemedicine practitioner must be licensed in the State in which
he or she is located as well as in any State(s) that he or she provides
telemedicine services to patients. Other commenters asked for
clarification on the term ``recognized'' as used in the proposed rule
and asked if it was equivalent to the ``privilege to practice''
authority provided for by Nurse Licensure Compact States. A few
commenters also stated that the licensure language was not clear and
further stated that if it was intended that the requirements would
allow for reciprocity agreements, endorsements, other compact
arrangements, or situations where a State does not require local
licensure, then the requirements should be amended to reflect this.
Response: We appreciate the suggestions offered by commenters.
However, we believe that the proposed licensure language provides
enough flexibility to hospitals and CAHs so that they may address these
issues in their required agreements with distant-site telemedicine
hospitals and entities. In fact, our intention was that they should
address such licensure issues in accordance with their respective State
laws and regulations. We neither endorse nor prohibit licensure
arrangements among States, which are mentioned above. Practitioners
providing telemedicine services, as well as the distant-site hospitals
and entities under whose auspices they provide these services, must be
aware of the licensure laws in the States where they are located in
addition to the laws, compacts, and arrangements of those States in
which they look to provide their services to patients.
CMS recognizes that practitioner licensure laws and regulations
have traditionally been, and continue to be, the provenance of
individual States, and we are not seeking to pre-empt State authority
in this matter. We believe that the proposed requirements regarding
State licensure leave room for the laws that exist today as well as any
changes to these laws that may occur in the future, including any
increase in the number of States that decide to engage in compacts,
privilege to practice or reciprocity agreements, endorsements, and
other arrangements regarding practitioner licensure. Therefore, we are
finalizing this aspect of the requirements as proposed.
Critical Access Hospital (CAH) CoPs (Sec. 485.616 and Sec. 485.641)
We proposed to make revisions to the CAH CoPs at Sec. 485.616,
``Agreements,'' and Sec. 485.641, ``Periodic evaluation and quality
assurance review.'' We specified in the proposed rule that the majority
of the proposed revisions, particularly those which mirror the proposed
hospital revisions, are found in the ``Agreements'' CoP, specifically
Sec. 485.616(c). At Sec. 485.616(c), we proposed a new standard
entitled, ``Agreements for credentialing and privileging of
telemedicine physicians and practitioners.''
The proposed telemedicine credentialing and privileging
requirements for CAHs are modeled after the hospital requirements, with
almost no differences in the regulatory language. Since the only
existing requirements in the CAH CoPs specific to the responsibility of
the governing body to grant medical staff privileges concerns surgical
privileges for practitioners, we proposed to add language that follows
the language in the hospital requirements at Sec. 482.12(a). This
language delineates the responsibilities of the governing body for the
professional staff privileging process.
At Sec. 485.641(b)(4)(iv), which does not have an equivalent
provision in the hospital CoPs, we proposed to make a minor change to
the CAH CoPs here. We proposed to add a new provision that would allow
the distant-site hospital to evaluate the quality and appropriateness
of the diagnosis and treatment furnished by its own staff when
providing telemedicine services to the CAH. This proposed change would
add distant-site hospitals to the three other entities already allowed
to perform this function under the existing regulations.
Comment: One commenter noted that we use slightly different
language in the requirements for CAHs than we do for the hospital
requirements, and stated that we do not discuss the reasons for the
differences in the preamble to the proposed rule. The commenter noted
that we state at Sec. 485.616(c)(2) that the CAH's ``governing body or
responsible individual may choose to rely upon the credentialing and
privileging decisions
[[Page 25558]]
made by the governing body of the distant-site hospital regarding
individual distant-site physicians or practitioners.''
Response: We thank the commenters for pointing out the discrepancy
between the regulatory language for hospitals and that for CAHs in this
instance. We have revised the hospital language to be consistent with
that for CAHs.
III. Provisions of the Final Rule
Based on public comment and our own internal discussions, we are
adding new provisions to this final rule that will apply to the
credentialing and privileging process and the agreements between
hospitals and CAHs and non-hospital, distant-site telemedicine entities
that provide telemedicine services (Sec. 482.12(a)(9) and Sec.
482.22(a)(4) for hospitals; Sec. 485.616(c)(3) and Sec. 485.616(c)(4)
for CAHs). These new provisions will require the governing body of the
hospital (or the CAH's governing body or responsible individual),
through its written agreement with the distant-site telemedicine
entity, to ensure that the distant-site telemedicine entity, acting as
a contractor of services, furnishes its services in a manner that
enables the hospital (or CAH) to comply with all applicable conditions
of participation and standards for the contracted services, including,
but not limited to, the credentialing and privileging requirements
regarding its physicians and practitioners providing telemedicine
services.
Essentially, the new provisions will allow for the governing body
of the hospital (or the CAH's governing body or responsible individual)
to rely upon the credentialing and privileging decisions made by the
distant-site telemedicine entity when making its own decisions on
privileges for the individual distant-site physicians and practitioners
providing such services, if the hospital's governing body (or the CAH's
governing body or responsible individual) ensures, through its written
agreement with the distant-site telemedicine entity, that the distant-
site telemedicine entity's medical staff credentialing and privileging
processes and standards meet or exceed the standards at Sec.
482.12(a)(1) through Sec. 482.12(a)(7) and Sec. 482.22(a)(1) through
Sec. 482.22(a)(2) for hospitals, and at Sec. 485.616(c)(1)(i) through
Sec. 485.616(c)(1)(vii) for CAHs. Additionally, the hospital's
governing body (or the CAH's governing body or responsible individual)
must ensure that the distant-site telemedicine entity, through a
written agreement, meets three other provisions finalized here (and
similar to those proposed and finalized here for agreements between
hospitals/CAHs and distant-site hospitals providing telemedicine
services).
Accordingly, we have made revisions to Sec. 482.22(c)(6) and Sec.
485.641(b)(4) to reference these new provisions pertaining to distant-
site telemedicine entities as finalized in this rule.
Additionally, we have made a revision to Sec. 485.635(c). This
standard currently requires a CAH to have agreements or arrangements
with one or more Medicare-participating providers or suppliers in order
to furnish other services to its patients. We saw that as an impediment
to the agreements that CAHs may have with distant-site telemedicine
entities under this final rule. Since these entities do not participate
in Medicare, we needed to make an exception to the requirement at Sec.
485.635(c)(1). We have added a new paragraph at Sec. 485.635(c)(5) to
provide an exception to this requirement in cases where a written
agreement exists between a CAH and a distant-site telemedicine entity
for the entity's distant-site physicians and practitioners to provide
telemedicine services to the CAH's patients.
In this final rule, we have made two significant clarifying
revisions to the language of the proposed rule.
In the requirements for both hospitals and CAHs pertaining to the
agreement with a distant-site hospital providing telemedicine services,
we have corrected an oversight in the proposed rule and have revised
the requirements in this final rule to clarify that these agreements or
contracts must be written.
We have also revised the hospital language to be more consistent
with that for CAHs, where we now state that the hospital's governing
body may choose to have its medical staff ``rely upon the credentialing
and privileging decisions made by the governing body of the distant-
site hospital regarding individual distant-site physicians or
practitioners.''
Finally, we have made a few minor clarifying revisions to the
proposed rule in those places where we found inconsistencies in
regulatory language and/or instances where we believe the language was
not as clear as it should have originally been.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We solicited public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. ICRs Regarding Condition of Participation: Governing Body (Sec.
482.12)
Section 482.12(a)(8) requires the governing body of a hospital to
ensure that, when telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site hospital, the
agreement is written and specifies that it is the responsibility of the
governing body of the distant-site hospital to meet the requirements in
paragraphs (1) through (7) of this section with regard to its
physicians and practitioners providing telemedicine services. The
burden associated with this requirement is the time and effort
necessary for a hospital's governing body to develop, review, and
update as necessary the agreement with a distant-site hospital. We
estimate that 4,860 hospitals (not including 1,314 CAHs) must develop
the aforementioned written agreement. We also estimate that the initial
development of the agreement will take 1,440 minutes at an estimated
cost of $1,996. Assuming at most an annual update, the review will take
360 minutes at an estimated cost of $516. The total cost associated
with this requirement is $2,512.
Section 482.12(a)(9) requires the governing body of a hospital to
ensure that, when telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site telemedicine entity,
the agreement is written and specifies that the distant-site
telemedicine entity is a contractor of services to the hospital and as
such, in accordance with Sec. 482.12(e), furnishes services that
permit the hospital to comply with all applicable conditions of
participation and standards for the contracted services,
[[Page 25559]]
including, but not limited to, the requirements in paragraphs (a)(1)
through (a)(7) of this section with regard to its physicians and
practitioners providing telemedicine services. The burden associated
with this requirement is the time and effort necessary for a hospital's
governing body to develop, review, and update as necessary the
agreement with a distant-site telemedicine entity. While this
requirement is subject to the PRA, the associated burden is accounted
for in our discussion of Sec. 482.12(a)(8).
B. ICRs Regarding Condition of Participation: Medical Staff (Sec.
482.22)
Section 482.22(a)(3) states that when telemedicine services are
furnished to a hospital's patients through an agreement with a distant-
site hospital, the governing body of the hospital whose patients are
receiving the telemedicine services may choose to have its medical
staff rely upon the credentialing and privileging decisions made by the
distant-site hospital when making recommendations on privileges for the
individual physicians and practitioners providing such services. To do
this, a hospital's governing body must ensure that all of the
provisions listed at Sec. 482.22(a)(3)(i) through (iv) are met.
Specifically, Sec. 482.22(a)(3)(iv) contains a third-party disclosure
requirement. Section 482.22(a)(3)(iv) requires that with respect to a
distant-site physician or practitioner, who holds current privileges at
the hospital whose patients are receiving the telemedicine services,
the hospital has evidence of an internal review of the distant-site
physician's or practitioner's performance of these privileges and sends
the distant-site hospital such information for use in the periodic
appraisal of the distant-site physician or practitioner. At a minimum,
this information must include all adverse events that result from the
telemedicine services provided by the distant-site physician or
practitioner to the hospital's patients and all complaints the hospital
has received about the distant-site physician or practitioner.
The burden associated with this third-party disclosure requirement
is the time and effort necessary for a hospital to send evidence of a
distant-site physician's or practitioner's performance review to the
distant-site hospital with which it has an agreement for providing
telemedicine services. We estimate 4,860 hospitals (not including 1,314
CAHs) must comply with this requirement. We estimate that each
disclosure will take 60 minutes and that there will be approximately 32
annual disclosures. The estimated cost associated with this requirement
is $1,088.
Section 482.22(a)(4) states that when telemedicine services are
furnished to the hospital's patients through an agreement with a
distant-site telemedicine entity, the governing body of the hospital
whose patients are receiving the telemedicine services may choose, in
lieu of the requirements in paragraphs (a)(1) and (a)(2) of this
section, to have its medical staff rely upon the credentialing and
privileging decisions made by the distant-site telemedicine entity when
making recommendations on privileges for the individual distant-site
physicians and practitioners providing such services, if the hospital's
governing body ensures, through its written agreement with the distant-
site telemedicine entity, that the distant-site telemedicine entity
furnishes services that, in accordance with Sec. 482.12(e), permit the
hospital to comply with all applicable conditions of participation and
standards for the contracted services. To do this, a hospital's
governing body must ensure that all of the provisions listed at Sec.
482.22(a)(4)(i) through (iv) are met. Specifically, Sec.
482.22(a)(4)(iv) contains a third-party disclosure requirement. Section
482.22(a)(4)(iv) states that with respect to a distant-site physician
or practitioner, who hold current privileges at the hospital whose
patients are receiving the telemedicine services, the hospital has
evidence of an internal review of the distant-site physician's or
practitioner's performance and sends the distant-site telemedicine
entity such information for use in the periodic appraisal of the
distant-site physician or practitioner. At a minimum, this information
must include all adverse events that result from the telemedicine
services provided to the hospital's patients by the distant-site
physician or practitioner and all complaints the hospital has received
about the distant-site physician or practitioner. While this
requirement is subject to the PRA, the associated burden is accounted
for in our discussion of Sec. 482.22(a)(3).
C. ICRs Regarding Condition of Participation: Agreements (Sec.
485.616)
Section 485.616(c)(1) states that the governing body of the CAH
must ensure that, when telemedicine services are furnished to the CAH's
patients through an agreement with a distant-site hospital, the
agreement is written and specifies that it is the responsibility of the
governing body of the distant-site hospital to meet the requirements
listed at Sec. 485.616(c)(1)(i) through (vii) and Sec. 485.616(c)(2).
The burden associated with this requirement is the time and effort
necessary for a CAH's governing body to develop, review, and update as
necessary the agreement with a distant-site hospital. We estimate that
1,314 CAHs must develop and review the aforementioned written
agreement. We also estimate that development of the agreement will take
1,440 minutes initially and, assuming at most an annual update, the
review will take 360 minutes annually. The total cost associated with
this requirement is $2,512.
Section 485.616(c)(2) states that when telemedicine services are
furnished to the CAH's patients through an agreement with a distant-
site hospital, the CAH's governing body or responsible individual may
choose to rely upon the credentialing and privileging decisions made by
the governing body of the distant-site hospital for individual distant-
site physicians or practitioners, if the CAH's governing body or
responsible individual ensures that all of the provisions listed at
Sec. 485.616(c)(2)(i) through (iv) are met. The burden associated with
this third-party disclosure requirement at Sec. 485.616(c)(2)(iv) is
the time and effort necessary for a CAH to send evidence of a distant-
site physician's or practitioner's performance review to the distant-
site hospital with which it has an agreement for providing telemedicine
services. We estimate 1,314 CAHs must comply with this requirement. We
estimate that each disclosure will take 60 minutes and that there will
be approximately 32 annual disclosures. The estimated cost associated
with this requirement is $1,088.
Section 485.616(c)(3) states that the governing body of the CAH
must ensure that, when telemedicine services are furnished to the CAH's
patients through an agreement with a distant-site telemedicine entity,
the agreement is written and specifies that the distant-site
telemedicine entity is a contractor of services to the CAH and as such,
in accordance with Sec. 485.635(c)(4)(ii), furnishes services that
enable the CAH to comply with all applicable conditions of
participation and standards for the contracted services, including, but
not limited to, the requirements in this section with regard to its
physicians and practitioners providing telemedicine services.
The burden associated with this requirement is the time and effort
necessary for a CAH's governing body to develop, review, and update as
necessary the agreement with a distant-site telemedicine entity. We
estimate that 1,314 CAHs must develop and review the aforementioned
written
[[Page 25560]]
agreement. We also estimate that development of the agreement will take
1,440 minutes (that is, 24 hours) initially and, assuming at most an
annual update, the review will take 360 minutes (six hours) annually.
The total cost associated with this requirement is $2,512.
Section 485.616(c)(4) states that when telemedicine services are
furnished to the CAH's patients through an agreement with a distant-
site telemedicine entity, the CAH's governing body or responsible
individual may choose to rely upon the credentialing and privileging
decisions made by the governing body of the distant-site telemedicine
entity regarding individual distant-site physicians or practitioners.
The CAH's governing body or responsible individual must ensure, through
its written agreement with the distant-site telemedicine entity, that
all of the provisions listed at Sec. 485.616(c)(4)(i) through (iv) are
met. The burden associated with this third-party disclosure requirement
at Sec. 485.616(c)(4)(iv) is the time and effort necessary for a CAH
to send evidence of a distant-site physician's or practitioner's
performance review to the distant-site telemedicine entity with which
it has an agreement for providing telemedicine services. While this
requirement is subject to the PRA, the associated burden is accounted
for in our discussion of Sec. 485.616(c)(2).
Table 1--Annual Reporting, Recordkeeping and Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly Total
Burden per Total labor cost labor cost Total
Regulation section(s) OMB Control No. Respondents Responses response annual of of capital/ Total cost
(hours) burden reporting reporting maintenance ($)
(hours) ($) ($) costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 482.12(a)(8) and (9)..... 0938-New............ 4,860 4,860 24 116,640 ** 9,700,560 0 9,700,560
.................... 4,860 4,860 6 29,160 ** 2,507,760 0 2,507,760
Sec. 482.22(a)(3) and (4)..... 0938-New............ 4,860 155,520 1 155,520 34 5,287,680 0 5,287,680
Sec. 485.616(c)(1) and (3).... 0938-New............ 1,314 1,314 24 31,536 ** 2,622,744 0 2,622,744
.................... 1,314 1,314 6 7,884 ** 678,024 0 678,024
Sec. 485.616(c)(2) and (4).... 0938-New............ 1,314 42,048 1 42,048 34 1,429,632 ........... 1,429,632
-------------------------------------------------------------------------------------------------
Total....................... .................... 6,174 209,916 .......... 382,788 .......... .......... ........... 22,226,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
** Wage rates vary by level of staff involved in complying with the information collection request (ICR). The wage rates associated with the
aforementioned information collection requirements are listed in Tables 2-7 in the regulatory impact analysis of this final rule.
V. Regulatory Impact Analysis
A. Statement of Need
Currently, a hospital or CAH receiving telemedicine services must
go through a burdensome credentialing and privileging process for each
physician and practitioner who will be providing telemedicine services
to its patients. In the past, under the Joint Commission's (TJC)
statutory deeming authority, hospitals that were accredited by TJC were
deemed to have met the CMS credentialing and privileging requirements.
TJC's ``privileging by proxy'' standards allowed for one Joint
Commission-accredited facility to accept the privileging decisions of
another Joint Commission-accredited facility. TJC has been statutorily
required to meet or exceed our requirements regarding credentialing and
privileging since July 15, 2010.
This final rule will revise the conditions of participation (CoPs)
for both hospitals and critical access hospitals (CAHs) and will
implement a new credentialing and privileging process for physicians
and practitioners furnishing telemedicine services. Additionally, and
perhaps more significantly, failure to publish this final rule will
place undue hardship and financial burden on those hospitals and CAHs
who have been credentialing and privileging telemedicine practitioners
under TJC's ``privileging by proxy'' model. These hospitals and CAHs
will have to take on the burden of credentialing and privileging a
significant number of telemedicine practitioners in a relatively short
period of time or they will have to consider canceling their
telemedicine services. Cancellation of telemedicine services by small
hospitals and CAHs will drastically reduce access to needed specialty
services for a great number of patients, many of whom are Medicare
beneficiaries.
B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This rule is not an economically significant rule and does not impose
significant costs. The benefits of finalizing this rule greatly
outweigh any costs imposed. Conversely, the negative impacts on overall
patient health and safety as well as on the operating costs of
individual hospitals and CAHs were this rule not to be finalized would
be significant compared to the minimal cost imposed by finalizing it
here. Accordingly, we have prepared a regulatory impact analysis, which
to the best of our ability, presents the costs and benefits of the
rulemaking.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100
[[Page 25561]]
million or more in any 1 year). The RFA requires agencies to analyze
options for regulatory relief of small businesses, if a rule has a
significant impact on a substantial number of small entities. For
purposes of the RFA, we estimate that the great majority of hospitals,
including CAHs, are small entities as that term is used in the RFA.
Individuals and States are not included in the definition of a small
entity. While we do not believe that this final rule will have a
significant impact on small entities, we do believe that this rule will
have a positive impact by providing immediate regulatory relief for
these small entities and will negatively impact them if not finalized
here. Therefore, we are voluntarily preparing a Regulatory Flexibility
Analysis.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This rule will not have a
significant impact on small rural hospitals as it is intended to
relieve the burden on hospitals, particularly on small rural hospitals
and CAHs, and to reduce or eliminate the impact of the current
regulatory impediments to efficient operation and patient access to
essential healthcare services. Therefore, the Secretary has determined
that this final rule will not have a significant negative impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2011, that
threshold is approximately $136 million. This rule does not contain
mandates that will impose spending costs on State, local, or tribal
governments in the aggregate, or by the private sector, of $136
million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This final rule will not have a substantial direct effect
on State or local governments, preempt State laws, or otherwise have a
Federalism implication.
C. Anticipated Effects
1. Effects on Hospitals and Critical Access Hospitals (CAHs)
We estimate the costs to hospitals and CAHs to implement this final
rule with comment period to be minimal, particularly when weighed
against the significant benefits that the rule would bring about by
reducing the regulatory burden for hospitals and CAHs. The major costs
are related to developing the agreement between the distant-site
hospital or distant-site telemedicine entity and the hospital or CAH at
which patients who receive the telemedicine services are located. Many
hospitals and CAHs may already have such telemedicine service
agreements in place and therefore would not incur the initial costs of
developing such an agreement.
Our figures, as of March 31, 2010, indicate that there were 4,860
hospitals and 1,314 CAHs (for a total of 6,174) participating in
Medicare in the United States. However, we have no way of determining
an exact number on which of these hospitals provide telemedicine
services and which of these hospitals and CAHs receive telemedicine
services, nor can we determine how many hospitals and CAHs already have
telemedicine agreements. We do not have any reliable figures on the
number of non-hospital, distant-site telemedicine entities that provide
telemedicine services to hospitals and CAHs. Accordingly, we have based
our cost estimates on the higher costs that would be incurred if every
hospital and CAH in the United States was required to develop an
agreement and review and update it annually. We prepared the cost
estimates for hospitals and CAHs separately. However, all sides of this
equation will require the initial services of a hospital or CAH
attorney at an average of $86/hour; a hospital or CAH chief of the
medical/professional staff (a physician) at an average of $103/hour;
and a hospital or CAH administrator at an average of $69/hour. For the
third-party disclosure requirements, we also prepared the cost
estimates for hospitals and CAHs separately, though both will require
the annual services of a medical staff credentialing manager or a
medical staff coordinator at an average of $34/hour. Our salary figures
are the most recent wage estimates from the Bureau of Labor Statistics
(http://www.bls.gov/home.htm) with 33% added to the hourly wage to
account for benefits. Our estimates of time and cost for each aspect of
the agreement (development and initial cost, and annual review), as
well as for the third-party disclosure, is as follows:
Table 2--Information Collection Requirements for a Hospital To Develop an Agreement for Telemedicine Services:
Initial Cost
----------------------------------------------------------------------------------------------------------------
Number of Cost per
Individual Hourly wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Attorney........................................ $86 12 $1,032 ..............
Physician....................................... 103 4 412 $1,996
Hospital Administrator.......................... 69 8 552 ..............
----------------------------------------------------------------------------------------------------------------
Table 3--Information Collection Requirements for a Hospital To Review and Update an Agreement for Telemedicine
Services: Annual Cost
----------------------------------------------------------------------------------------------------------------
Number of Cost per
Individual Hourly wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Attorney........................................ $86 2 $172 ..............
Physician....................................... 103 2 206 $516
Hospital Administrator.......................... 69 2 138 ..............
----------------------------------------------------------------------------------------------------------------
[[Page 25562]]
Therefore, we estimate the total initial cost to develop the
agreement for all 4,860 hospitals to be $9.7 million. The annual cost
to review agreements for all hospitals is estimated at $2.5 million.
Table 4--Information Collection Requirements for a CAH To Develop an Agreement for Telemedicine Services:
Initial Cost
----------------------------------------------------------------------------------------------------------------
Number of Cost per
Individual Hourly wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Attorney........................................ $86 12 $1,032 ..............
Physician....................................... 103 4 412 $1,996
CAH Administrator............................... 69 8 552 ..............
----------------------------------------------------------------------------------------------------------------
Table 5--Information Collection Requirements for a CAH To Review and Update an Agreement for Telemedicine
Services: Annual Cost
----------------------------------------------------------------------------------------------------------------
Number of Cost per
Individual Hourly wage hours individual Total cost
----------------------------------------------------------------------------------------------------------------
Attorney........................................ $86 2 $172 ..............
Physician....................................... 103 2 206 $516
Hospital Administrator.......................... 69 2 138 ..............
----------------------------------------------------------------------------------------------------------------
Therefore, we estimate the total initial cost to develop the
agreement for all 1,314 CAHs to be $2.6 million. The annual cost to
review agreements for all CAHs is estimated at $678,024.
Table 6--Information Collection Requirements for a Hospital To Prepare and Send Individual Performance Reviews
for Telemedicine Services (Third-Party Disclosure): Annual Cost
----------------------------------------------------------------------------------------------------------------
Number of
Individual Hourly wage hours Total cost
----------------------------------------------------------------------------------------------------------------
Medical Staff Coordinator or Medical Staff Credentialing Manager $34 32 $1,088
----------------------------------------------------------------------------------------------------------------
Therefore, we estimate the total annual cost to prepare and send
individual performance reviews for telemedicine services (third-party
disclosure) for all 4,860 hospitals to be $5.3 million.
Table 7--Information Collection Requirements for a CAH To Prepare and Send Individual Performance Reviews for
Telemedicine Services (Third-Party Disclosure): Annual Cost
----------------------------------------------------------------------------------------------------------------
Number of
Individual Hourly wage hours Total cost
----------------------------------------------------------------------------------------------------------------
Medical Staff Coordinator or Medical Staff Credentialing Manager $34 32 $1,088
----------------------------------------------------------------------------------------------------------------
Therefore, we estimate the total annual cost to prepare and send
individual performance reviews for telemedicine services (third-party
disclosure) for all 1,314 CAHs to be $1.4 million.
The total cost of the information collection requirements for both
hospitals and CAHs is estimated to be $22.2 million.
D. Conclusion
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 482
Grant programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
42 CFR Part 485
Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
1. The authority citation for part 482 continues to read as follows:
Authority: Secs. 1102, 1871 and 1881 of the Social Security Act
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
Subpart B--Administration
0
2. Section 482.12 is amended by adding new paragraphs (a)(8) and (a)(9)
to read as follows:
Sec. 482.12 Condition of participation: Governing body.
* * * * *
(a) * * *
[[Page 25563]]
(8) Ensure that, when telemedicine services are furnished to the
hospital's patients through an agreement with a distant-site hospital,
the agreement is written and that it specifies that it is the
responsibility of the governing body of the distant-site hospital to
meet the requirements in paragraphs (a)(1) through (a)(7) of this
section with regard to the distant-site hospital's physicians and
practitioners providing telemedicine services. The governing body of
the hospital whose patients are receiving the telemedicine services
may, in accordance with Sec. 482.22(a)(3) of this part, grant
privileges based on its medical staff recommendations that rely on
information provided by the distant-site hospital.
(9) Ensure that when telemedicine services are furnished to the
hospital's patients through an agreement with a distant-site
telemedicine entity, the written agreement specifies that the distant-
site telemedicine entity is a contractor of services to the hospital
and as such, in accordance with Sec. 482.12(e), furnishes the
contracted services in a manner that permits the hospital to comply
with all applicable conditions of participation for the contracted
services, including, but not limited to, the requirements in paragraphs
(a)(1) through (a)(7) of this section with regard to the distant-site
telemedicine entity's physicians and practitioners providing
telemedicine services. The governing body of the hospital whose
patients are receiving the telemedicine services may, in accordance
with Sec. 482.22(a)(4) of this part, grant privileges to physicians
and practitioners employed by the distant-site telemedicine entity
based on such hospital's medical staff recommendations; such staff
recommendations may rely on information provided by the distant-site
telemedicine entity.
* * * * *
Subpart C--Basic Hospital Functions
0
3. Section 482.22 is amended by--
0
A. Adding new paragraphs (a)(3) and (a)(4).
0
B. Revising paragraph (c)(6).
The addition and revision read as follows:
Sec. 482.22 Condition of participation: Medical staff.
* * * * *
(a) * * *
(3) When telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site hospital, the
governing body of the hospital whose patients are receiving the
telemedicine services may choose, in lieu of the requirements in
paragraphs (a)(1) and (a)(2) of this section, to have its medical staff
rely upon the credentialing and privileging decisions made by the
distant-site hospital when making recommendations on privileges for the
individual distant-site physicians and practitioners providing such
services, if the hospital's governing body ensures, through its written
agreement with the distant-site hospital, that all of the following
provisions are met:
(i) The distant-site hospital providing the telemedicine services
is a Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site hospital providing the telemedicine
services, which provides a current list of the distant-site physician's
or practitioner's privileges at the distant-site hospital.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the hospital whose
patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the hospital whose patients are receiving
the telemedicine services, the hospital has evidence of an internal
review of the distant-site physician's or practitioner's performance of
these privileges and sends the distant-site hospital such performance
information for use in the periodic appraisal of the distant-site
physician or practitioner. At a minimum, this information must include
all adverse events that result from the telemedicine services provided
by the distant-site physician or practitioner to the hospital's
patients and all complaints the hospital has received about the
distant-site physician or practitioner.
(4) When telemedicine services are furnished to the hospital's
patients through an agreement with a distant-site telemedicine entity,
the governing body of the hospital whose patients are receiving the
telemedicine services may choose, in lieu of the requirements in
paragraphs (a)(1) and (a)(2) of this section, to have its medical staff
rely upon the credentialing and privileging decisions made by the
distant-site telemedicine entity when making recommendations on
privileges for the individual distant-site physicians and practitioners
providing such services, if the hospital's governing body ensures,
through its written agreement with the distant-site telemedicine
entity, that the distant-site telemedicine entity furnishes services
that, in accordance with Sec. 482.12(e), permit the hospital to comply
with all applicable conditions of participation for the contracted
services. The hospital's governing body must also ensure, through its
written agreement with the distant-site telemedicine entity, that all
of the following provisions are met:
(i) The distant-site telemedicine entity's medical staff
credentialing and privileging process and standards at least meet the
standards at Sec. 482.12(a)(1) through (a)(7) and Sec. 482.22(a)(1)
through (a)(2).
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site telemedicine entity providing the
telemedicine services, which provides the hospital with a current list
of the distant-site physician's or practitioner's privileges at the
distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the hospital whose
patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the hospital whose patients are receiving
the telemedicine services, the hospital has evidence of an internal
review of the distant-site physician's or practitioner's performance of
these privileges and sends the distant-site telemedicine entity such
performance information for use in the periodic appraisal of the
distant-site physician or practitioner. At a minimum, this information
must include all adverse events that result from the telemedicine
services provided by the distant-site physician or practitioner to the
hospital's patients, and all complaints the hospital has received about
the distant-site physician or practitioner.
* * * * *
(c) * * *
(6) Include criteria for determining the privileges to be granted
to individual practitioners and a procedure for applying the criteria
to individuals requesting privileges. For distant-site physicians and
practitioners requesting privileges to furnish telemedicine services
under an agreement with the hospital, the criteria for determining
privileges and the procedure for applying the criteria are also subject
to the requirements in Sec. 482.12(a)(8) and (a)(9), and Sec.
482.22(a)(3) and (a)(4).
* * * * *
[[Page 25564]]
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
4. The authority citation for part 485 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).
Subpart F--Conditions of Participation: Critical Access Hospitals
(CAHs)
0
5. Section 485.616 is amended by adding a new paragraph (c) to read as
follows:
Sec. 485.616 Condition of participation: Agreements.
* * * * *
(c) Standard: Agreements for credentialing and privileging of
telemedicine physicians and practitioners. (1) The governing body of
the CAH must ensure that, when telemedicine services are furnished to
the CAH's patients through an agreement with a distant-site hospital,
the agreement is written and specifies that it is the responsibility of
the governing body of the distant-site hospital to meet the following
requirements with regard to its physicians or practitioners providing
telemedicine services:
(i) Determine, in accordance with State law, which categories of
practitioners are eligible candidates for appointment to the medical
staff.
(ii) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff.
(iii) Assure that the medical staff has bylaws.
(iv) Approve medical staff bylaws and other medical staff rules and
regulations.
(v) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients.
(vi) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment.
(vii) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the hospital dependent solely
upon certification, fellowship or membership in a specialty body or
society.
(2) When telemedicine services are furnished to the CAH's patients
through an agreement with a distant-site hospital, the CAH's governing
body or responsible individual may choose to rely upon the
credentialing and privileging decisions made by the governing body of
the distant-site hospital regarding individual distant-site physicians
or practitioners. The CAH's governing body or responsible individual
must ensure, through its written agreement with the distant-site
hospital, that the following provisions are met:
(i) The distant-site hospital providing telemedicine services is a
Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site hospital providing the telemedicine
services, which provides a current list of the distant-site physician's
or practitioner's privileges at the distant-site hospital;
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the CAH is located;
and
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the CAH whose patients are receiving the
telemedicine services, the CAH has evidence of an internal review of
the distant-site physician's or practitioner's performance of these
privileges and sends the distant-site hospital such information for use
in the periodic appraisal of the individual distant-site physician or
practitioner. At a minimum, this information must include all adverse
events that result from the telemedicine services provided by the
distant-site physician or practitioner to the CAH's patients and all
complaints the CAH has received about the distant-site physician or
practitioner.
(3) The governing body of the CAH must ensure that when
telemedicine services are furnished to the CAH's patients through an
agreement with a distant-site telemedicine entity, the agreement is
written and specifies that the distant-site telemedicine entity is a
contractor of services to the CAH and as such, in accordance with Sec.
485.635(c)(4)(ii), furnishes the contracted services in a manner that
enables the CAH to comply with all applicable conditions of
participation for the contracted services, including, but not limited
to, the requirements in this section with regard to its physicians and
practitioners providing telemedicine services.
(4) When telemedicine services are furnished to the CAH's patients
through an agreement with a distant-site telemedicine entity, the CAH's
governing body or responsible individual may choose to rely upon the
credentialing and privileging decisions made by the governing body of
the distant-site telemedicine entity regarding individual distant-site
physicians or practitioners. The CAH's governing body or responsible
individual must ensure, through its written agreement with the distant-
site telemedicine entity, that the following provisions are met:
(i) The distant-site telemedicine entity's medical staff
credentialing and privileging process and standards at least meet the
standards at paragraphs (c)(1)(i) through (c)(1)(vii) of this section.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site telemedicine entity providing the
telemedicine services, which provides a current list to the CAH of the
distant-site physician's or practitioner's privileges at the distant-
site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the State in which the CAH whose
patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the CAH whose patients are receiving the
telemedicine services, the CAH has evidence of an internal review of
the distant-site physician's or practitioner's performance of these
privileges and sends the distant-site telemedicine entity such
information for use in the periodic appraisal of the distant-site
physician or practitioner. At a minimum, this information must include
all adverse events that result from the telemedicine services provided
by the distant-site physician or practitioner to the CAH's patients and
all complaints the CAH has received about the distant-site physician or
practitioner.
0
6. Section 485.635 is amended by adding a new paragraph (c)(5) to read
as follows:
Sec. 485.635 Condition of participation: Provision of services.
* * * * *
(c) * * *
(5) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site telemedicine entity, the
distant-site telemedicine entity is not required to be a Medicare-
participating provider or supplier.
* * * * *
0
7. Section 485.641 is amended by revising paragraph (b)(4) to read as
follows:
[[Page 25565]]
Sec. 485.641 Condition of participation: Periodic evaluation and
quality assurance review.
* * * * *
(b) * * *
(4) The quality and appropriateness of the diagnosis and treatment
furnished by doctors of medicine or osteopathy at the CAH are evaluated
by--
(i) One hospital that is a member of the network, when applicable;
(ii) One QIO or equivalent entity;
(iii) One other appropriate and qualified entity identified in the
State rural health care plan;
(iv) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site hospital, the distant-site
hospital; or
(v) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site telemedicine entity, one
of the entities listed in paragraphs (b)(4)(i) through (iii) of this
section; and
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare
Supplementary Medical Insurance Program). (Catalog of Federal
Domestic Assistance Program No. 93.778, Medical Assistance Program)
Dated: January 27, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: April 29, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-10875 Filed 5-2-11; 11:15 am]
BILLING CODE 4120-01-P